Post-bariatric Abdominoplasty: Skin Sensation Evaluation

Federal University of São Paulo

Status: Completed

Conditions: Hypesthesia; Obesity

Treatments: Procedure: Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.; Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)

Study type: Interventional

Funder types: Other

Identifiers

NCT00831610

UNIFESP-712/06

Details and patient eligibility

About

The purpose of this study is to quantify the skin sensation of the anterior abdominal wall of the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining.

Additional purposes were: quantify topographically the abdominal skin sensation of the Normal weight, Morbid Obese and Former Morbid Obese after bariatric surgery (before and after the abdominoplasty - excess skin surgical removal without flap undermining -> Anchor Line Abdominoplasty).

Full description

Abdominoplasty performed in post-bariatric patients presents more post-operative complications than in non post-bariatric patients. Surgical techniques that provokes less complications are required.

Anchor-line abdominoplasty is a technique published in the years 1950 as well the first bariatric proceedings. Abdominoplasty without flap undermining is feasible in pendular abdominal wall of the former morbidly obese women with scarred abdomen.

Classical abdominoplasty (with flap undermining) is known to impair significantly the skin sensation. Post-bariatric abdominoplasty without flap undermining keeps the skin sensation unaltered since the early post-operative period.

Now that the post-bariatric anchor-line abdominoplasty improves the abdominal wall contour by removing the exceeding, pendular and striated skin saving the perforant skin sensory nerves. Could this technique improve the skin sensation of the anterior abdominal wall of the post-bariatric patients?

Enrollment: 100 patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Former morbidly obese women with Body Mass Index superior of 40kg/m2.
• Post-bariatric surgery: Roux en Y gastric bypass.
• Clinical conditions to perform a plastic surgery.

Exclusion criteria

• Diabetes.
• Peripheral neuropathy.
• Deny to sign the Informed Consent Term.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

STUDY

Other group

Description:

1. Female healthy volunteers (25 to 55 years old) with normal weight. 2. Morbid Obese women waiting for bariatric surgery. 3. Post-bariatric female patients, 25 to 55 years old, MORE than 12 months of weight stability, pendular abdominal wall, clinical conditions to anchor-line abdominoplasty without flap undermining. Skin Evaluation before the abdominoplasty. 4. Group 3, submitted to anchor-line abdominoplasty without flap undermining.

Treatment:

Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)

Procedure: Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.

CONTROL

Other group

Description:

Group 3: Post-bariatric female patients, 25 to 55 years old, LESS than 12 months of weight stability, pendular abdominal wall, clinical conditions to anchor-line abdominoplasty without flap undermining. Who will be submitted to abdominoplasty after the study period.

Treatment:

Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)